Cytomedix, Inc. (OTC/BB: CMXI) is a biotech company that creates, develops and commercializes advanced tissue regeneration technology. Their wound healing management predominantly focuses on the utilization of platelets and platelet derivatives in order to treat chronic wounds. Their most advanced product, AutoloGel PRP System, creates a quick separation and activation of platelet rich plasma (PRP) from the patient’s blood. The PRP is then processed to produce a gel, which is then applied to the wound, re-establishing a balance needed for natural healing to occur.
Cytomedix announced the implementation of a letter agreement allowing an undisclosed global pharmaceutical company an exclusivity period until December 31, 2011 to conduct further due diligence with regard to AutoloGel PRP System. As compensation, Cytomedix received a $2 million non-refundable option fee. The product received FDA marketing clearance (510K) in September 2007. A year later it launched commercially.
“We are very pleased to be approaching a key milestone in the broad commercialization of the AutoloGel System. Over the next several weeks, we will be focused on pursuing a robust agreement that delivers value to our shareholders while advancing our long standing commitment to have this therapy appropriately positioned and more widely marketed in the underserved chronic wound care market. We will have no further comment on the specifics of this potential transaction until a definitive agreement is reached,” said Martin P. Rosendale, Chief Executive Officer of Cytomedix.
In normal wound healing, platelets migrate from the blood into a wound site, where they serve as a primary source of growth factors. These proteins are essential for healing and are released by platelets to help manage the movement of cells, the formation of new blood vessels, cell growth, cell differentiation and deposition of new tissue. However, in chronic wounds and other tissues where blood supply may be low, the delivery of platelets is often disrupted, so adequate wound healing stalls. In this case, a patients’ own platelet rich plasma can be activated to generate a fibrin rich gel that serves as a rich source of growth factors, cytokines and chemokines to re-establish balance in the wound bed. The PRP System restores the balance of the wound environment and promotes the patient’s natural healing processes.
5-7 million people suffer every year from chronic or complex wounds that are typically difficult to heal. They tend to cause unusual hardship and depression. These wounds can lead to complications such as infection, pain, and limb amputation. Patients with diabetes are at greatest risk of attaining chronic wounds. 15 percent of the estimated 17 million Americans with diabetes may suffer from chronic wounds, most commonly non-healing foot sores, which can lead to amputation. The remaining percentage of chronic wounds result from pressure ulcers, peripheral neuropathy, peripheral vascular disorders, arterial occlusive disease, radiation, osteomyelitis and insect bites.